Mark D. Kramer, RAC, is President, Regulatory Strategies, Inc., a regulatory consultancy specializing in medical devices and combination products. He has more than 35 years’ experience in regulatory affairs, including 17 years at the US Food and Drug Administration culminating in his position as Director of FDA’s Office of Combination Products from 2002 to 2007. From 2007-2010, Mark was Regulatory Affairs Executive and Chief Regulatory Strategist at GE Healthcare, where he had responsibility for US, Canadian and Latin American regulatory affairs for the medical device business. Mark served on the Board of Directors of the Regulatory Affairs Professional Society (RAPS) from 2009-2014, served as Chair of the Wisconsin RAPS Chapter from 2007-2010, and is an adjunct faculty member for St. Cloud State University’s Master’s program in regulatory affairs. He currently serves on the RAPS Affiliate Board. Mark can be reached at